Bladder CancerNCT01688414
Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer
A study testing photoacoustic imaging, fluorescence imaging and robot-assisted laparoscopic surgery in people with Bladder Cancer and Kidney Tumor, run by Stanford University.
Trial summary
This pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate, bladder, or kidney cancer Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer, Kidney Tumor, Prostate Cancer
- What is being tested?
- photoacoustic imaging, fluorescence imaging and robot-assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a pathologic confirmation of prostate cancer, bladder cancer, or kidney cancer based on previous biopsies or procedures OR a strong concern for a kidney malignancy based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with a surgical history or anatomic variant that would preclude robot assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia repair with mesh)
- Patients with medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation
- Patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dL
About this study
Official title: Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery
This pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate, bladder, or kidney cancer
Read the detailed description
PRIMARY OBJECTIVES:
- The primary objective of this pilot study is to assess the ability of fluorescent imaging and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant tissue.
SECONDARY OBJECTIVES:
- To qualitatively determine the possible benefit of PAI and fluorescent imaging over traditional white light imaging.
OUTLINE:
Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
- Conditions
- Bladder Cancer, Kidney Tumor, Prostate Cancer
- Being tested
- photoacoustic imaging, fluorescence imaging, robot-assisted laparoscopic surgery
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Renal Cell, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photoacoustic imagingProcedure or surgery
Also called optoacoustic imaging, PAI
Undergo PAI
fluorescence imagingProcedure or surgery
Undergo fluorescence imaging
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo robot-assisted laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (fluorescence imaging, PAI) | Experimental | Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery. Receives: Procedure: photoacoustic imaging; Procedure: fluorescence imaging; Procedure: robot-assisted laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer])
The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.
Measured: Up to 6 months after surgery
Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)
The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Measured: During the time of surgery
Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements
The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Measured: During the time of surgery
Fluorescence intensity (signal-to-noise ratio in the region of interest)
The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Measured: During the time of surgery
Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements
The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Measured: During the time of surgery
Secondary outcomes (3)
Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
Measured: During the time of surgery
Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
Measured: During the time of surgery
Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging).
Measured: During the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
Why it stopped: PI left Stanford
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Gonzalgo, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688414
- Sponsor's protocol ID
- VAR0083
- Other IDs
- NCI-2012-01654
- Status last verified
- Jul 2014
- First submitted
- 12 Sep 2012
- Last updated
- 29 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT01688414
- Acronym / sponsor ID
- VAR0083
- Conditions
- Bladder Cancer, Kidney Tumor, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left Stanford
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate, bladder, or kidney cancer
Detailed description
PRIMARY OBJECTIVES:
- The primary objective of this pilot study is to assess the ability of fluorescent imaging and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant tissue.
SECONDARY OBJECTIVES:
- To qualitatively determine the possible benefit of PAI and fluorescent imaging over traditional white light imaging.
OUTLINE:
Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (fluorescence imaging, PAI) | Experimental | Procedure: photoacoustic imaging, Procedure: fluorescence imaging, Procedure: robot-assisted laparoscopic surgeryPatients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have a pathologic confirmation of prostate cancer, bladder cancer, or kidney cancer based on previous biopsies or procedures OR a strong concern for a kidney malignancy based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (3 listed)
- Patients with a surgical history or anatomic variant that would preclude robot assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia repair with mesh)
- Patients with medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation
- Patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photoacoustic imagingAlso: optoacoustic imaging, PAIUndergo PAI | Procedure or surgery | Diagnostic (fluorescence imaging, PAI) |
| fluorescence imagingUndergo fluorescence imaging | Procedure or surgery | Diagnostic (fluorescence imaging, PAI) |
| robot-assisted laparoscopic surgeryUndergo robot-assisted laparoscopic surgery | Procedure or surgery | Diagnostic (fluorescence imaging, PAI) |
Primary outcome
Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer])
Time frame: Up to 6 months after surgery
The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample.
Photoacoustic signal intensity (signal-to-noise ratio in the region of interest)
Time frame: During the time of surgery
The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements
Time frame: During the time of surgery
The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Fluorescence intensity (signal-to-noise ratio in the region of interest)
Time frame: During the time of surgery
The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements
Time frame: During the time of surgery
The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
3 secondary outcomes
Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
Time frame: During the time of surgery
Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
Time frame: During the time of surgery
Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
Time frame: During the time of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Gonzalgo principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing photoacoustic imaging, fluorescence imaging and robot-assisted laparoscopic surgery in people with Bladder Cancer and Kidney Tumor, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer]) (time frame: Up to 6 months after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.